BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOSPRAY ABLATION SYSTEM

    MDR report key: 4634936 · Received March 24, 2015

    Report

    Report Number
    3004534508-2015-00003
    Event Type
    Injury
    Date Received
    March 24, 2015
    Date of Event
    September 30, 2009
    Report Date
    March 24, 2015
    Manufacturer
    CSA MEDICAL INC
    Product Code
    GEH
    PMA / PMN Number
    K072651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT UPPER GI ENDOSCOPE WITH SPRAY CRYOTHERAPY FOR BARRETT'S ESOPHAGUS WITH DYSPLASIA ON (B)(6) 2009. ON (B)(6) 2009 THE PATIENT NOTED BLOODY DIARRHEA AND BLOOD IN STOOL WAS CONFIRMED BY PCP, AS WAS HEMATOCRIT OF 30%. PATIENT WAS TRANSFUSED WITH 2 UNITS OF PACKED RED BLOOD CELLS. THE PATIENT'S PLAVIX WAS STARTED 5 DAYS AFTER THE SPRAY CRYOTHERAPY PROCEDURE AND THE MD FELT THIS WAS RELATED TO THE BLEEDING. THE PLAN FOR FUTURE SCT PROCEDURES CALLS FOR STOPPING PLAVIX 5 DAYS PRIOR TO THE PROCEDURE AND RESTARTING IT 2 WEEKS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198176 CRYOSPRAY ABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH CSA MEDICAL INC CC2-NAM

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention