Adverse Event reported on 3/30/2012

Device Attributes
AttributeValue
Manufacturer
Brand Name
Device TypeCRYOBALLOON ABLATION
Product CodeGEH
Model Number
Catalog Number
Device Operator0
CRYOBALLOON ABLATION   Back to Search Results
Event Date 03/27/2012
Event Type  Death   Patient Outcome  Death
Event Description

A (b)(6) female with history of atrial fibrillation underwent an (b)(6) study with cryoballoon ablation on (b)(6) 2012. She presented to the emergency department on (b)(6) 2012, with hematemesis and intercranial hemorrhage. She was emergently intubated and underwent an upper endoscopy which noted an esophageal perforation/erosion and possible atrial fistula. She subsequently died of the complications of the cryoablation.

 
Source: FDA