# K161202: C2 Cryoballoon Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: C2 Therapeutics, Inc.
- Decided: Jan 5, 2017 after 252 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K943450 (1995). 68 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152329: Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System, C2 Therapeutics, Inc. (2016) Summary page 4.

## Most influential descendants
- K163684: C2 CryoBalloon Ablation System (2018), 4 descendants of its own
- K190194: C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge (2019), 3 descendants of its own
- K203024: C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge (2020), 2 descendants of its own
- K212814: C2 CryoBalloon Ablation System (2021), 1 descendant of its own
- K240457: C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) (2024), 0 descendants of its own

## Recalls of this device
- Jan 6, 2017 · Class II · Z-1477-2017: The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could compromise the integrity and result in damage to the Controller Cap.

## Indications for use
The C2 CryoBalloon™ Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett’s Esophagus with dysplasia.

Source page: https://510kreport.com/device/K161202
Methodology: https://510kreport.com/methodology