C2 THERAPEUTICS, INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Unit, Cryosurgical, Accessories (GEH) (8) Endoscopic Access Overtube, Gastroenterology-Urology (FED) (1) Endoscopic Irrigation/Suction System (OCX) (1)

Premarket Exempt

Clear

Controller, Full/Swipe - 00854924006064 Catalog Number : FG-1006

Device Description : Controller for Full and Swipe C2 CryoBalloon Ablation System (translating)

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Catheter, Full, Standard - 00854924006088 Catalog Number : FG-1008

Device Description : C2 CryoBalloon Full Catheter with Standard Balloon for C2 CryoBalloon Ablation System

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

C2 CryoBalloon Focal Catheter, Standard - 00854924006095 Catalog Number : FG-1009

Device Description : C2 CryoBalloon Focal Catheter with Standard Balloon for C2 CryoBalloon Ablation System

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

C2 CryoBalloon Cartridge, Regular - 00854924006101 Catalog Number : FG-1010

Device Description : C2 CryoBalloon Cartridge, Regular, for C2 CryoBalloon Ablation System

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Sidecar External Working Channel - 00854924006118 Catalog Number : FG-1011

Device Description : Sidecar External Working Channel, Endoscopic Accessory

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : FED

Prescription Use : Yes

Device Count : 1

C2 CryoBalloon Focal Controller - 00854924006125 Catalog Number : FG-1012

Device Description : C2 CryoBalloon Focal Controller for C2 CryoBalloon Ablation System

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

C2 CryoBalloon Cartridge, Large - 00854924006132 Catalog Number : FG-1013

Device Description : C2 CryoBalloon Cartridge for C2 CryoBalloon Ablation System

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

C2 CryoBalloon Swipe Catheter, Standard - 00854924006156 Catalog Number : FG-1015

Device Description : C2 CryoBalloon Swipe Catheter with Standard Balloon for C2 CryoBalloon Ablation System

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

BOA Endoscopic Valve - 00854924006163 Catalog Number : FG-1016

Device Description : BOA Endoscopic Valve, Endoscopic Accessory

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

C2 CryoBalloon - 00854924006170 Catalog Number : FG-1017

Device Description : Controller

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

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