BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C2 CRYOBALLOON ABLATION SYSTEM

    MDR report key: 6122242 · Received November 22, 2016

    Report

    Report Number
    3008780134-2016-00015
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    October 29, 2016
    Report Date
    November 22, 2016
    Manufacturer
    C2 THERAPEUTICS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K131523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND NOT RETURNED TO THE MANUFACTURER. THIS COMPLAINT COULD NOT BE FURTHER INVESTIGATED. NO ADVERSE EVENT WAS OBSERVED AT THE TIME OF ABLATION.

    Description of Event or Problem · 1

    THE PATIENT HAD A CARDIAC HISTORY AND WAS TAKING DUAL ANTIPLATELET THERAPY. HE HAD A CORONARY ARTERY ANEURYSM CLOT AND WAS TAKING AN ANTICOAGULANT (EFFIENT), WHICH THE CARDIOLOGIST DID NOT WANT TO STOP AND UNDERSTOOD RISK OF BLEEDING. ON (B)(6) 2016 HE WAS TREATED FOR BARRETT'S ESOPHAGUS WITH INTRAMUCOSAL CANCER USING C2 CRYOABLATION. THERE WERE NO EVENTS DURING THE PROCEDURE. ON (B)(6) 2016 HE WAS ADMITTED TO A DIFFERENT HOSPITAL FOR UPPER GASTROINTESTINAL BLEEDING. ENDOSCOPY WAS PERFORMED, AND A BLEEDING VESSEL WAS CLIPPED. ON (B)(6)2016 HIS HEMOGLOBIN DROPPED TO 6, HE WAS TRANSFUSED, AND AN ENDOSCOPY WAS PERFORMED. THERE WAS NO EVIDENCE OF VISIBLE BARRETT'S ESOPHAGUS. ON NOVEMBER 7 HE WAS AT HOME AND NO LONGER TAKING EFFIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771876 C2 CRYOBALLOON ABLATION SYSTEM CRYOSURGICAL UNIT AND ACCESSORIES GEH C2 THERAPEUTICS, INC. FG 1012, FG 1009

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R