# K212814: C2 CryoBalloon Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Nov 29, 2021 after 87 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K943450 (1995). 72 ancestors in all.
1 later device descends 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)
- K203024: C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge, Pentax of America, Inc. (2020) Summary page 4.

## Most influential descendants
- K240457: C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) (2024), 0 descendants of its own

## 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/K212814
Methodology: https://510kreport.com/methodology